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GeoVax Announces Initiation of HIV Human Clinical Trial
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today the initiation of the next human clinical trial of GeoVax’s preventive HIV vaccine, GOVX-B11. The Phase 1 trial (designated HVTN 114) is being conducted by the HIV Vaccine Trials Network (HVTN) and is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase 2a trial of the GOVX-B11 vaccine (concluded in 2012) and will test the ability of late boosts (additional vaccinations) to increase the antibody responses elicited by the GeoVax vaccine. These “late boosts” will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, supplied by Global Solutions for Infectious Diseases (GSID), is the same protein used to boost immune responses in the partially protective RV144 trial in Thailand, and is being used here to assess the effect of late boosts of GOVX-B11 while newer proteins are cGMP manufactured and safety tested for use with GOVX-B11 in future clinical trials. Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone.
Harriet L. Robinson, Ph.D., director of the Company’s HIV vaccine program, commented, “We are pleased to announce the start of this study, as it will provide important information on the durability of immune responses elicited by GOVX-B11 and the effects of late MVA and protein boosts on the elicitation of antibody by GOVX-B11. Information from this trial will contribute to the design of human clinical trials testing our vaccine in the presence and absence of the gp120 proteins that are currently being prepared for use with GOVX-B11.”
GOVX-B11 is being developed for use against the clade B subtype of HIV prevalent in the Americas and Western Europe. Despite advancements in drug treatment, data from the U.S. Centers for Disease Control and Prevention (CDC) indicate that only a minority (~30%) of HIV-infected Americans successfully control their infections with drugs. HIV diagnosis rates are increasing in American youth faster than in other age groups. In those aged 13 to 24, the incidence of HIV increased at an estimated average annual rate of 10.5% between 2002 and 2011. With the increasing burden of the epidemic, healthcare costs are also growing. The development of an effective HIV vaccine is critical to bringing an end to the HIV/AIDS pandemic.
GOVX-B11 consists of two vaccine components – a recombinant DNA vaccine to prime a person’s immune response and a recombinant MVA (modified vaccinia Ankara) vaccine to boost the primed response. Both the DNA and MVA vaccines produce non-infectious virus-like particles in the cells of the vaccinated person. With NIAID’s support, GOVX-B11 has been tested at various doses and regimens by the HVTN in trials involving approximately 500 participants where it has shown excellent safety and reproducible immunogenicity. In August 2016, NIAID awarded GeoVax a Staged Vaccine Development contract of approximately $200,000 with additional development options of up to $7.6 million to manufacture the DNA component of GOVX-B11 for use in future clinical trials.
The HVTN is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy. Primary funding for the HVTN is provided by the NIAID. HVTN trial sites are located at leading research institutions in 27 cities on four continents. The Network’s headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington. For more information, go to www.hvtn.org.
GSID is a non-profit global health organization engaged in the development of diagnostic and preventive tools for infectious diseases, including HIV. GSID provides assistance to, and collaborates with, global public health organizations, private foundations, other non-governmental organizations and for-profit entities focused on public health issues and infectious diseases. The focus of GSID is to facilitate the access to affordable health solutions for the benefit of the people most in need, particularly in developing countries. For more information, go to www.gsid.org.
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Virus Ankara-Virus Like Particles (MVA-VLP) vaccine platform. The Company’s development programs are focused on vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.